Recruiting NA Kidney Stone

New treatment option for Kidney Stone

Official title Access Sheath and Stent Trial

ClinicalTrials.gov ID: NCT07297953

What this study is testing

What it's testing
The study is being completed to compare patient reported outcomes for stent omission vs. placement after using a ureteral access sheath for uncomplicated ureteroscopy.
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Planned ureteroscopy using a Ureteral Access Sheath (UAS) for treatment of unilateral kidney and/or ureteral stones in patients that have an existing...
  • Planned treatment of unilateral renal and/or ureteral stones, in a single procedure.
  • Renal stone defined as only renal location of stone(s)

You likely can't join if

  • Pregnancy
  • Ureteric injury during ureteroscopy (PULS ≥ Grade 2)
  • Evidence of ureteral stricture
  • Anatomical abnormalities (e.g., solitary, horseshoe, fused crossed ectopia, pelvic kidney, urinary diversion)
  • Known planned secondary or staged procedure
  • Indwelling nephrostomy tube
See the full eligibility criteria
Who can join
  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Planned ureteroscopy using a Ureteral Access Sheath (UAS) for treatment of unilateral kidney and/or ureteral stones in patients that have an existing ureteral stent (pre-stented)
  • Planned treatment of unilateral renal and/or ureteral stones, in a single procedure.
  • Renal stone defined as only renal location of stone(s)
  • Ureteral stone defined as ureteral only location of stone(s)
  • Ureteral and renal stone(s)
  • No evidence of significant ureteral injury on intra-operative assessment (Post-Ureteroscopy Lesion Scale (PULS) Grade 0 or 1)
  • Ability and willingness to complete and adhere to survey questions and responses throughout study duration.
What rules you out
  • Pregnancy
  • Ureteric injury during ureteroscopy (PULS ≥ Grade 2)
  • Evidence of ureteral stricture
  • Anatomical abnormalities (e.g., solitary, horseshoe, fused crossed ectopia, pelvic kidney, urinary diversion)
  • Known planned secondary or staged procedure
  • Indwelling nephrostomy tube
  • Bilateral ureteroscopy

The study team makes the final eligibility decision.

Where it's taking place

  • Ann Arbor, Michigan, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.